Pentaerythritol compositum

Package leaflet: Information for the patient

PENTAERYTHRITOL COMPOSITUM
20 mg + 0,5 mg, tablets
Pentaerythritol tetranitrate + Glyceryl trinitrate
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Pentaerythritol compositum is and what it is used for
2. Important information before taking Pentaerythritol compositum
3. How to take Pentaerythritol compositum
4. Possible side effects
5. How to store Pentaerythritol compositum
6. Contents of the pack and other information

1. What Pentaerythritol compositum is and what it is used for

Pentaerythritol compositum has a coronary vasodilating effect.
It is used prophylactically and therapeutically in ischemic heart disease and in acute exacerbations of ischemic heart disease.

2. Important information before taking Pentaerythritol compositum

When not to take Pentaerythritol compositum

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has hypotension, including that associated with hypovolemia (reduced circulating blood volume),
• if the patient has suffered a myocardial infarction (especially of the right ventricle) and has low systolic blood pressure and/or tachycardia (accelerated heart rate),
• if the patient has hypertrophic cardiomyopathy with left ventricular outflow tract obstruction,
• if the patient has mitral valve stenosis or aortic valve stenosis,
• if the patient has constrictive pericarditis,
• if the patient has increased intracranial pressure, including hemorrhagic stroke and head trauma,
• if the patient has cerebral hemorrhage,
• if the patient has significant anemia,
• if the patient has narrow-angle glaucoma,
• if the patient has congestive venous disease or thrombotic disorders,
• if the patient is taking phosphodiesterase type 5 inhibitors (e.g. sildenafil) – used for erectile dysfunction.

Warnings and precautions
Before starting treatment with Pentaerythritol compositum, discuss this with your doctor.
Exercise particular caution:

• in patients with renal and/or hepatic impairment,
• in patients with low blood pressure due to various diseases,
• in hyperthyroidism and hypothyroidism.

Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
Use of Pentaerythritol compositum in elderly patients
Dosage adjustment is not required in elderly patients.
Children
The safety and efficacy of the medicine have not been studied in children.
Pentaerythritol compositum and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use. This especially includes the following medicines, as concomitant use may cause undesirable lowering of arterial blood pressure with symptoms of hypotension:

• other vasodilating agents,
• beta-blockers,
• calcium antagonists,
• angiotensin II antagonists,
• diuretics,
• angiotensin-converting enzyme (ACE) inhibitors,
• neuroleptics, tricyclic antidepressants,
• other antihypertensive medicines.

Also inform your doctor about the use of the following medicines:

• non-steroidal anti-inflammatory drugs (which may reduce the efficacy of nitrates),
• dihydroergotamine (possibility of increased arterial blood pressure).

During treatment with Pentaerythritol compositum (as well as other nitrates), it is absolutely forbidden to take phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil), used for erectile dysfunction, due to the risk of severe, life-threatening adverse reactions.
Pentaerythritol compositum with food, drink and alcohol
The medicine should be taken at least half an hour before a meal or one hour after a meal.
Alcohol intensifies the blood pressure-lowering effect of nitrates.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Consult a doctor before using the medicine.
Breastfeeding
Due to the passage of nitrates into breast milk, consult a doctor before using the medicine.
Driving and operating machinery
Pentaerythritol compositum has a moderate effect on the ability to drive and operate machinery.
At the beginning of treatment, headache and orthostatic hypotension (low blood pressure in the standing position) may occur; in particularly sensitive individuals, fainting may occur. If such symptoms occur, the patient should not drive or operate machinery.
Pentaerythritol compositum contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Pentaerythritol compositum contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take the medicine Pentaerythritol compositum

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor.
Dosage
Adults
The recommended dose is 1 to 2 tablets three times daily.
A lower initial dose (1 tablet three times daily) is recommended when this medicine is used for the first time, due to the possibility of hypotension (reduction of blood pressure below normal values).
Patients with renal and (or) hepatic impairment
In patients with renal and (or) hepatic impairment, the doctor may recommend lower doses depending on the degree of renal and (or) hepatic impairment, and then gradually increase the dose under supervision.
Method of administration
Oral administration. To accelerate the effect of the medicine, the tablet may be chewed and then swallowed.
It is recommended to take the medicine at least half an hour before a meal or one hour after a meal.
Taking more than the recommended dose of Pentaerythritol compositum
If more than the recommended dose has been taken, consult a doctor immediately. In cases of poisoning with this medicine, symptomatic treatment is applied.
Symptoms of overdose include: facial flushing, hypotension, restlessness, increased heart rate, headaches, pulsating sensation in the head, dizziness, weakness, increased sweating, nausea, vomiting, skin allergic reactions, methemoglobinemia (presence of abnormal hemoglobin in the blood).
Missed dose of Pentaerythritol compositum
Do not take a double dose to make up for a missed dose.
Stopping treatment with Pentaerythritol compositum
Avoid abrupt discontinuation of the medicine (except in cases of occasional hypersensitivity). If treatment needs to be stopped, the doctor will recommend gradually reducing the doses.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicinal products, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of the possible adverse effects listed below is defined as follows:

• very common (affects at least 1 in 10 people),
• common (affects at least 1 in 100, but less than 1 in 10 people),
• uncommon (affects at least 1 in 1,000, but less than 1 in 100 people),
• rare (affects at least 1 in 10,000, but less than 1 in 1,000 people),
• very rare (affects less than 1 in 10,000 people),
• unknown (frequency cannot be estimated from the available data).

Very common:
headache (usually mild and subsiding after a few days of taking the medicine).

Uncommon:
facial skin redness, sensation of warmth (due to vasodilation, sometimes requiring discontinuation of the medicine).

Rare:
severe headache (requiring discontinuation of the medicine), transient weakness, dizziness, increased intraocular pressure, gastrointestinal disturbances: nausea, vomiting, abdominal pain (usually mild and transient).

Very rare:
severe hypotension, fainting, reflex bradycardia, increased intracranial pressure, rash, rosacea, erythroderma, redness, skin inflammation, epidermal exfoliation.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Pentaerythritol compositum

Store below 25°C.
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Pentaerythritol compositum contains

• The active substances in the medicine are: pentaerythritol tetranitrate 20 mg and glyceryl trinitrate 0.5 mg.
• The other ingredients are: sucrose, potato starch, lactose monohydrate, talc, sodium carboxymethyl starch type A, magnesium stearate, gelatin.

What Pentaerythritol compositum looks like and contents of the pack
Pentaerythritol compositum is available as tablets. The tablet is white, round, and slightly convex on both sides.
The packaging contains 20 tablets in a glass vial closed with a polyethylene stopper, placed in a cardboard box with a patient information leaflet.

Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy "GALENA"
ul. Dożynkowa 10
52-311 Wrocław
Poland
Tel.: +48 71 710 62 01